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GOST 31881-2012 Principles of Good Laboratory Practice The role and responsibilities of the study director in the application of GLP Principles《良好实验室操作规程原则 GLP研究中的研究主管作用和职责》.pdf

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1、 (GLP) GLP , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)318812012, - 1.092 . 1.22009 . -, . , , 1 : - , , ( ); 339 , ; 339 , 2 3 , ( 9 2012 . 53-) : ( 3166) 00497 ( 3166) 00497 AMBYKGMDRUTJ -4 OECD series on rinciples of GoodLaboratory Practice and Compliance Monitorin

2、g No 8 The role and responsibilities of the study director inGLP studies:1999 ( , - : 1999, 8 - () GLP ). GLP. (en). , , . (IDT). : . 5 27 2012 . 2158- 318812012 - 1 2013 .6 II 318812012 , - . () . - , , 2013 -, III 3188120121 .12 13 23.1 23.2 .24 .24.1 34.2 34.3 .34.4 .44.5 .45 45.1 , .45.2 46 47 .

3、 .48 .59 .6 6IV 318812012 - () (GLP), 58 1992 . (Interlaken), , - ., GLP (Dr. David F.Moore), GLP ; - , - (Dr. Heinz Reust). - GLP, , , , , , , , . . GLP 1993 . , - . 20- . 1997 . GLP - , GLP , ( -) 1999 ., , 1999 .V 318812012 (GLP) GLPPrinciples of Good Laboratory Practice (GLP).The role and respon

4、sibilities of the study director in the application of GLP Principles1 , - GLP.2 2.1 , . , - GLP . , , , , , ; .2.2 , , . , ,.- , ,/ .2.3 - , , , , . , -, .2.4 , , , , . - . , - /() (), .1 318812012 201301012.5 - , , , - -.2.6 () . , GLP, , GLP.3 GLP, - , - , () ().3.1 , , () -(), GLP. . , , -, - , - . / .3.2 . -, GLP - , , (, ). . , , , - . , - . - . , , - . , . , , .4 , - - .2 3188120124.1 , - . -, . . , , () ()() , - . , , , - ( ). , , , - . , - G

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